Ishibashi, K., Okada, N., Miyazaki, T., Sano, M., & Ishida, H. (2010). Effect of calcium and magnesium on neurotoxicity and blood platinum concentrations in patients receiving mFOLFOX6 therapy: A prospective randomized study. International Journal of Clinical Oncology, 15, 82–87.
To evaluate the effectiveness of calcium/magnesium (Ca/Mg) infusions in reducing the incidence and severity of oxaliplatin-related neurotoxicity and to evaluate the effects of Ca/Mg infusions on progression-free survival and platinum plasma levels in patients with colorectal cancer
Patients with metastatic colorectal cancer were randomized and double-blinded to receive mFOLFOX6 with a Ca/Mg infusion (100 ml of 5% glucose-containing calcium gluconate of 850 mg and magnesium sulfate of 720 mg) before and after the administration of oxaliplatin or mFOLFOX6 with placebo (100 ml of 5% glucose alone) before and after administration of oxaliplatin (85 mg/m2) every two weeks for six cycles. Prior to administration, patients were assessed for adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, by nurses or pharmacists.
Prospective, randomized, double-blind, controlled trial in patients with metastatic colorectal cancer receiving mFOLFOX6
Ca/Mg infusion prior to and after mFOLFOX6 did not reduce the incidence of grade 1–3 neurotoxicity using two different standardized measures for neurotoxicity (DEB-NTS and CTCAE) after the completion of six cycles; response rates, disease control rates, and median survival times were not significantly different between groups. No significant differences existed in the plasma platinum levels between groups (Ca/Mg versus placebo) at any time point using the pre-established significance value of p < 0.05. Also, no significant difference in plasma platinum levels existed in those who developed grade 2 neuropathy compared to those who developed less severe neuropathy (DEB-NTS). When comparing those who achieved a partial or complete remission with mFOLFOX6 to those who achieved no response, plasma platinum levels did not differ, suggesting that calcium and magnesium infusions did not influence the efficacy of mFOLFOX6 chemotherapy.
Ca/Mg infusions before and after oxaliplatin did not reduce the incidence or severity of neurotoxic symptoms in patients with metastatic colorectal receiving mFOLFOX6.
The administration of Ca/Mg before and after oxaliplatin as a preventive measure to reduce the incidence or severity of oxaliplatin-related peripheral neuropathy in patients with colorectal cancer receiving mFOLFOX6 for six cycles has no clinical benefit.
Ishibashi, K., Ishida, H., Kuwabara, K., Ohsawa, T., Okada, N., Yokoyama, M., & Kumamoto, K. (2014). Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: Results of a prospective randomized non-inferiority trial. Surgery Today, 44, 716–722.
To investigate the effects of single-dose versus multiple-dose antimicrobial prophylaxis on surgical site infections (SSI) in patients undergoing elective surgery for rectal cancer
All patients received a preoperative bowel cleansing, kanamycin and erythromycin orally within 24 hours prior to surgery, and 1 g of a second-generation cephalosporin IV perioperatively. After surgery, patients were randomized to receive either single-dose prophylaxis one hour after surgery or an additional five doses over two consecutive days. Wounds were inspected daily in the hospital and in the clinic 30 days after surgery. The trial was designed to detect a 10% difference in the incidence of SSIs between groups.
Noninferiority randomized, controlled trial
The incidence of incision site infections was 5% in the single-dose group and 7.1% in the multiple-dose group. Organ/space infections were 10.8% in the single-dose group and 8.6% in the multiple-dose group. Several organ/space infections were related to anastomotic dehiscence. Overall, the incidence of SSIs was 13.7% with single-dose prophylaxis and 13.6% with multiple-dose prophylaxis. Subgroup analysis by specific surgical procedure did not show any significant differences between groups.
Single-dose, postoperative, intravenous, antimicrobial prophylaxis demonstrated similar results to that of multiple-dose prophylaxis. Multiple antimicrobial doses did not show improved benefit for the prevention of surgical site infections
A single dose of IV antibiotic prophylaxis after rectal surgery for cancer had similar outcomes to that of multiple postoperative antibiotic doses. These findings show there is no benefit to more doses of prophylactic postoperative antibiotics for the prevention of SSIs.
Isaacs, C., Robert, N.J., Bailey, F.A., Schuster, M.W., Overmoyer, B., Graham, M., . . . Kaye, J.A. (1997). Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin. Journal of Clinical Oncology, 15, 3368–3377.
Patients were assigned randomly to receive either placebo or interleukin-11 (IL-11) 50 mcg/kg/day subcutaneous (SC). The study drug was blinded. Randomization was stratified by investigative site and also by whether patients had received any prior chemotherapy. SC administration began on day two and was given for a minimum of 10 days after the first cycle of chemotherapy.
Sixty-seven patients were assessable. Sixty-eight percent of patients in the IL-11 group did not receive transfusions, versus 41% in the placebo group (p = .04). The IL-11 group had a decreased total number of platelet transfusions (p = .03) and time to platelet recovery to greater than 50K in the second cycle (p = .01). Side effects in the IL-11 group (p < .05) were peripheral edema (68%), dyspnea (48%), pleural effusion (18%), and conjunctival infection (25%).
Irwin, M.L., Cartmel, B., Gross, C.P., Ercolano, E., Li, F., Yao, X., . . . Ligibel, J. (2015). Randomized exercise trial of aromatase inhibitor-induced arthralgia in breast cancer survivors. Journal of Clinical Oncology, 33, 1104–1111.
To examine the effects of an exercise intervention on the severity of aromatase inhibitor (AI)-induced arthralgia in women with breast cancer
Patients were randomly assigned to a year-long exercise program consisting of twice weekly supervised resistance training and home-based aerobic exercise for 150 minutes per week. Participants wore heart rate monitors during workouts, and after each exercise session, participants recorded exercise type, duration, and average heart rate in logs. The aerobic component was usually brisk walking although patients could choose other activities such as stationary bike use. Strength training consisted of six exercises with gradually increasing weight. Women in the usual care group were instructed to continue usual activities. Those in the usual care group received monthly phone calls to determine AI adherence.
Randomized, controlled trial
Women assigned to exercise increased their physical activity by an average of 159 minutes per week compared to an average of 49 minutes per week in the usual care group (p < 0.001). Over 12 months, worst joint pain decreased by 29% in the exercise group while usual care patients showed a 3% increase (p < 0.001). The same patterns were shown in the DASH and osteoarthritis index measures. There was no dose response from exercise effects on arthralgia pain or functional measures. Adherence to AIs was 76% in the usual care group and 80% in the exercise group. AI-associated joint pain worsened slightly over time in the usual care group. The strongest benefit of exercise was seen after 12 months.
The findings of this study suggested that an exercise program including aerobic, resistance, and strength training may reduce pain from arthralgia caused by AIs among women with breast cancer.
Exercise has been recommended for patients with cancer to ameliorate multiple symptoms. This study showed that exercise also can reduce arthralgia-related pain associated with AIs and improve function among breast cancer survivors. Nurses can educate patients regarding the numerous benefits of exercise and can encourage and recommend regular exercise.
Irani, J., Salomon, L., Oba, R., Bouchard, P., & Mottet, N. (2010). Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncology, 11(2), 147-154.
Compare the efficacy of 3 drugs in preventing hot flashes in men receiving hormone treatment for prostate cancer
Patients were randomly assigned to receive wither venlafaxine delayed release 75 mg/day, medroxyprogesterone 20 mg/day or cyproterone acetate 100 mg/day in addition to leuprorelin injections. Patients were followed up at 4, 8 and 12 weeks. Patients completed daily hot flush diaries and categorised hot flush severity
Double blind randomized controlled trial
Patients in the medroxyprogesterone group had higher hot flash scores at baseline. The reduction in daily hot flush scores at 4 weeks was significantly lower for all 3 groups (p<.0001). Improvements were significantly lower in the venlafaxine group than either of the other 2 groups ( p = .0006), and patients ratings of efficacy of treatment showed that significantly fewer patients in the venlafaxine group rated the treatment as good ( p<.0001) compared to the other 2 groups. Adverse events related to the study drugs were not significantly different between groups, though cyproterone led to a non significantly higher number of vascular adverse events. The most frequent adverse events were gastrointestinal, including pain, constipation, diarrhea and nausea. GI events were more frequent with venlafaxine.
Men with significant hot flushes during androgen suppression for prostate cancer appeared to respond better to cyproterone acetate and medroxyprogesterone acetate than to venlafaxine
It appears that hormonal treatment is more effective in than venlafaxine for management of hot flashes in patients who are receiving androgen suppression for prostate cancer. Results also showed that many men did not seek treatment for this problem, suggesting that nurses may need to directly assess these patients for problems with hot flash symptoms. Effects of steroidal anti androgens on prostate cancer are not clear, and patients receiving both androgen suppression and cyproterone or medroxyprogesterone could have increases in prostate specific antigen concentrations.
International Society of Lymphology. (2009). The diagnosis and treatment of peripheral lymphedema. 2009 Concensus Document of the International Society of Lymphology. Lymphology, 42(2), 51–60. Retrieved from http://www.u.arizona.edu/~witte/contents/2009.42.2.concensus.pdf
To review the evidence regarding evaluation and management of patients with peripheral lymphedema
This International Society of Lymphology (ISL) Consensus Document is the current revision of the 1995 Document for the evaluation and management of peripheral lymphedema. It is based on modifications that were
Search strategy was not provided.
The consensus included the following components.
The following Research Agenda has been proposed.
Lymphedema may be simple or complex but should not be neglected. Accurate diagnosis and effective therapy is now available, and lymphology itself is now recognized as an important specialty in which clinicians are carefully trained in the intricacies of the lymphatic system, lymph circulation, and related disorders. The emerging era of molecular lymphology should result in improved understanding, evaluation, and treatment in clinical lymphology. Limited evidence exists regarding treatment. Basic recommendations are meticulous skin hygiene and care and range of motion exercise with compression. This document provides extensive information on the state of knowledge and areas for future research in lymphedema prevention and management.
Inoue, M., Shoji, M., Shindo, N., Otsuka, K., Miura, M., & Shibata, H. (2015). Cohort study of consistency between the compliance with guidelines for chemotherapy-induced nausea and vomiting and patient outcome. BMC Pharmacology and Toxicology, 16, 5-015-0005-1.
To assess compliance with chemotherapy-induced nausea and vomiting (CINV) guidelines and effects on patient outcomes
Patients were assessed for early and delayed CINV using the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). Chemotherapy and anti-emetic agents used were extracted from medical records, along with MAT results. Comparison was made between agents used and current practice guidelines used in the organization. Guidelines were dexamethasone for lowly emetogenic chemotherapy (LEC), either triple drug or doublet antiemetics for moderately emetogenic chemotherapy (MEC), and triple drug antiemetics for highly emetogenic chemotherapy (HEC).
PHASE OF CARE: Active antitumor treatment
Retrospective cohort
Overall compliance with guidelines was 87.7%-98.6% for early phase CINV prophylaxis and 87% for delayed phase. Delayed phase compliance with LEC was 97.4%, with MEC was 82.4%, and with HEC was 54.5%. In the LEC group, CINV was not prevented in 11.3%, where guidelines were used, and 29% in the undertreated group. In the MEC group, it was not prevented in 11.8% with guidelines and 14.3% in the undertreated group. In the HEC group, CINV was not prevented in 45.5% with guidelines and 50% in the undertreated group.
Adherence to CINV prophylaxis guidelines was associated with better CINV prevention compared to undertreated patients; however, adherence to HEC guidelines was low, adherence was particularly low for delayed phase prevention, and guidelines based on emetogenicity of chemotherapy alone appear to be insufficient for CINV prophylaxis, particularly with HEC regimens.
The findings suggest that following professional CINV prophylaxis guidelines may be helpful for CINV control, although insufficient for control with HEC chemotherapy. Adherence to preventive guidelines for delayed phase CINV and HEC appears to be more problematic. Guideline adherence alone based on emetogenicity of chemotherapy appears to be insufficient to achieve complete control of CINV. Nurses need to advocate for consideration of individual risk factors in planning CINV prevention and ensure care planning for delayed phase interventions. Lack of delayed phase effectiveness also points to the need to ensure that patients have medication for any breakthrough CINV and that patients are adherent to medication regimens for prevention.
Ingersoll, G.L., Wasilewski, A., Haller, M., Pandya, K., Bennett, J., He, H., … Berry, C. (2010). Effect of Concord grape juice on chemotherapy-induced nausea and vomiting: Results of a pilot study. Oncology Nursing Forum, 37, 213–221.
To determine the feasibility of administering a flavonoid-rich adjunctive treatment (Concord grape juice) for the management of chemotherapy-induced nausea and vomiting (CINV)
Eligible patients were randomized to either the experimental group, which received Concord grape juice, or the control group, which received a placebo composed of water, sweeteners, food-grade acids, natural grape essence, and food coloring (but no fruit juice).
Both groups drank 4 oz. of the grape juice or placebo beginning the evening of the treatment day and 30 minutes prior to meals for seven days following each of four chemotherapy treatments; an additional 4 oz. could be taken as needed for nausea. All patients received standard medical management of CINV.
The study was conducted at a single outpatient setting in northeastern United States.
All patients were in active treatment.
This pilot study was a double-blind, randomized clinical trial.
This study did not show any benefit of grape juice flavonoids for management of CINV.
The effect of grape juice flavonoids on CINV should be investigated further with a larger sample to determine whether preliminary findings are supported. Use may be limited because of intolerance of very sweet juice.
Flowers, C. R., Seidenfeld, J., Bow, E. J., Karten, C., Gleason, C., Hawley, D. K., . . . Ramsey, S. D. (2013). Antimicrobial prophylaxis and outpatient management of fever and neutropenia in adults treated for malignancy. Journal of Clinical Oncology, 31, 794–810.
To provide guidelines for antimicrobial prophylaxis and management of febrile neutropenia (FN) for adult outpatients with neuropathy.
The resource was a consensus-based guideline. A literature search examined articles indexed in MEDLINE (January 1987–April 2011). A systematic review of 47 articles from 43 studies were included in the analysis. Keywords included terms for malignant diseases; terms for neutropenia, infection, or fever; and terms for clinical guidelines, systematic reviews, meta-analyses, or clinical trials.
Articles were included if they were fully published English language reports on the topics of antimicrobials for the prevention of infection in neutropenic outpatient patients with cancer (with or without fever), direct comparisons of outcomes between inpatient and outpatient management of FN in patients with cancer, and methods to quantify risk of complications in patients with cancer and FN. Articles were excluded if they were meeting abstracts, commentaries, letters, editorials, case reports, and nonsystematic reviews.
Patients were undergoing the active treatment phase of care.
A table of recommendations addressed three main areas of concern: (a) preventing infection in patients at risk for neutropenia undergoing chemotherapy, (b) identifying which patients with cancer and FN may be safely treated as outpatients, and (c) identifying interventions for the outpatient management of FN.
These guidelines help clinicians determine which patients require hospitalization and which can safely be treated in the outpatient setting. The guidelines also aid in selecting appropriate antimicrobial prophylaxis for neutropenic patients.
Inaba, H., Cao, X., Pounds, S., Pui, C.H., Rubnitz, J.E., Ribeiro, R.C., & Razzouk, B.I. (2011). Randomized trial of two dosages of prophylactic granulocyte–colony-stimulating factor after induction chemotherapy in pediatric acute myeloid leukemia. Cancer, 117, 1313–1320.
The purpose of the study was to compare effects of two different doses of G-CSF in pediatric patients receiving high-dose chemotherapy.
Patients receiving induction chemotherapy were randomly assigned to receive either 5 mcg/kg or 10 mc/kg G-CSF daily after the first and second chemotherapy induction courses. Differences in number of neutropenic days, hospital days, number of febrile neutropenic episodes, episodes of infection, use of IV antibiotics, antifungal therapy courses, number of transfusions, cost of supportive care, and estimates of event-free survival.
Single-site inpatient location
The phase of care was active antitumor treatment.
The application was for pediatrics.
Double-blind, randomized, controlled trial
No significant differences were noted between study groups in number of neutropenic days, episodes of febrile neutropenia, days of hospitalization, episode of antibiotic and antifungal therapy, transfusions, or cost of supportive care. There was no difference between groups in proportion of complete responses, or estimates of event-free and overall survival.
No difference was noted in measured outcomes between groups of patients treated with two different doses of G-CSF.
Findings suggest that lower daily doses of prophylactic G-CSF can be as effective as higher doses in pediatric patients during induction chemotherapy. Dosage and timing of prophylactic G-CSF is not fully clear.